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Synaffix ADC Technology Enters the Clinic as Collaboration with ADC Therapeutics Advances

On January 16, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic (Press release, Synaffix, JAN 16, 2019, View Source [SID1234532771]).

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ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "AXL is a novel and ideal target for an ADC approach, as it is overexpressed in many solid tumor types. We look forward to exploring the effect of ADCT-601 on patients with selected advanced solid tumors who have failed or are intolerant to any established therapy. With five ADCs in eight ongoing clinical trials for multiple indications, we believe our highly targeted therapies have the potential to meaningfully improve outcomes for patients with solid tumors and hematological cancers."

The open-label, multicenter, single-arm trial will include a Phase Ia dose-escalation part followed by a Phase Ib dose-expansion part. The dose-escalation part is designed to determine the maximum tolerated dose of ADCT-601. The identified dose will be evaluated in the dose-expansion part. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03700294).

About ADCT-601

ADCT-601 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human AXL, conjugated using GlycoConnect technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalized into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is being evaluated in a Phase I clinical trial in patients with advanced solid tumors (NCT03700294).

Kitov Announces Pricing of $6 Million Registered Direct Offering

On January 16, 2019 Kitov Pharma Ltd. (NASDAQ/TASE:KTOV), an innovative biopharmaceutical company, reported that it has entered into definitive agreements with institutional investors providing for the issuance of 3,428,572 American Depositary Shares (ADS) at a purchase price of $1.75 per ADS in a registered direct offering (Press release, Kitov Pharmaceuticals , JAN 16, 2019, View Source [SID1234532769]).

Kitov will also issue unregistered warrants to purchase up to 2,571,430 ADSs. The warrants will have a term of 5.5 years, be exercisable immediately following the issuance date and have an exercise price of $2.00 per ADS. The offering is expected to result in gross proceeds of approximately $6 million.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The closing of the sale of the securities is expected to take place on or about January 18, 2019, subject to satisfaction of customary closing conditions.

The ADSs described above were offered pursuant to a shelf registration statement on Form F-3 (File No. 333-215037), which was declared effective by the United States Securities and Exchange Commission (the "SEC") on December 14, 2016. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

When filed with the SEC, copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained at the SEC’s website at View Source Copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

The warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Mirati Therapeutics Announces Proposed Public Offering Of Common Stock

On January 16, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it intends to offer and sell, subject to market and other conditions, $75.0 million of shares of its common stock in an underwritten public offering (Press release, Mirati, JAN 16, 2019, View Source [SID1234532703]). Mirati expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares are being offered by Mirati. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC are acting as joint book-running managers in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Publication in ImmunoHorizons Highlights the Role of IL-27 in Upregulation of Multiple Checkpoint Proteins

On January 16, 2019 Surface Oncology (Nasdaq:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the publication of a paper describing the biological activity of IL-27, an immunosuppressive cytokine (Press release, Surface Oncology, JAN 16, 2019, View Source [SID1234532698]). Previously, IL-27 has been referred to as a key regulator for the expression of checkpoint proteins.1

The paper, "IL-27 and TCR Stimulation Promote T Cell Expression of Multiple Inhibitory Receptors," was published in ImmunoHorizons, a peer-reviewed, open access, online-only journal committed to advancing the knowledge of immunology. Among the findings in the paper, results indicate that the local production of IL-27 at sites of ongoing toxoplasmosis-induced inflammation contributes to expression of PD-L1, LAG-3, CTLA-4, and TIGIT, all key checkpoint proteins in the downregulation of immune responses.

IL-27 is understood to play an important role in turning off an immune response following viral and parasitic infections. Beyond the role of IL-27 in restoring immunostasis, Surface Oncology believes it has identified several cancers where IL-27 may prevent the immune system from recognizing and killing cancer cells.

"This paper is yet another validation of the role of IL-27 as a regulatory cytokine for the upregulation of checkpoint proteins. We are rapidly working toward filing an IND for our IL-27 antibody, SRF388, which we believe will be the first IL-27 antibody for the treatment of cancer. We applaud this additional work in the field and are privileged to work alongside thought leaders such as Dr. Chris Hunter, one of our SAB members and senior author of this paper," said Jeff Goater, chief executive officer of Surface Oncology.

"We have now known for more than 15 years that IL-27 can have remarkable suppressive activities," said Christopher Hunter, B.Sc., Ph.D., chairman, Department of Pathobiology, University of Pennsylvania, and member of Surface Oncology’s Scientific Advisory Board. "However, the ability of IL-27 to promote inhibitory receptor expression in the context of infection, autoimmune inflammation, and cancer may help to explain how it tempers T cell responses."

Surface Oncology is currently conducting IND-enabling studies for its IL-27 antibody, SRF388. IND submission for SRF388 is projected for Q4 2019. SRF388 is believed to be the only IL-27 antibody in late-preclinical development.

1 Kuchroo, Et al. Nature 558, pages 454–459 (2018)

ABOUT SRF388
SRF388 is a fully human anti-IL-27 antibody. In preclinical studies, treatment with SRF388 was observed to block IL-27 signaling and its downstream immunosuppressive signaling effects. Preclinical combination with a PD-1 inhibitor increased the production of key inflammatory cytokines. SRF388 also demonstrates preclinical anti-metastatic tumor activity.

Under Surface’s collaboration agreement with Novartis, Novartis has the right to purchase an option to the SRF388 program.

Massive Bio Announces SYNERGY-AI Trial-in-Progress Poster Presentation at Upcoming ASCO Gastrointestinal Cancers Symposium 2019, and Opens a New Patient Contact and Clinical Research Center to Enable Rapid Access to Clinical Trials

On January 16, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry (Press release, Massive Bio, JAN 16, 2019, View Source [SID1234532689])." will be presented by Selin Kurnaz, PhD., a lead investigator, at the ASCO (Free ASCO Whitepaper)-Gastrointestinal Cancers Symposium on January 19, 2019 in San Francisco, California, USA.

The poster, Abstract # TPS717, is available at View Source, and discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry which can be found at ClinicalTrials.Gov View Source, is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We are very excited to be among the highly selected group of clinical trials and registries to be presented at the largest GI Oncology meeting in the United States. It is our goal to continue to promote precision oncology approaches at the point-of-care and enable easy access to clinical trials at scale to all cancer patients, while reducing operational complexities and costs. We are the first oncology dedicated company that has achieved the ability to combine patient centricity, technology and sub-specialist expertise while consistently delivering quadruple better results than national averages in clinical trial enrollment," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

Massive Bio has also expanded its Patient Contact and Clinical Research Center and opened a second location in Newtown, Pennsylvania, in addition to its main headquarters in New York City. This center is staffed with a team of oncology nurse navigators, patient advocates and research coordinators and focuses on Massive Bio’s growing portfolio of clinical trials and patient support services. The center is designed to have 24/7 customer support, patient pre-screening and real-world analytics capabilities to further guide and assist patients enrolling in all-phases of clinical trials.

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "We are very pleased to have our patient support division grow both in New York and Pennsylvania, and continue to be trusted by some of the world’s top CROs, pharmaceutical companies, patient advocacy groups, and the many patients who are reaching out to our call center directly every day". Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "We look forward to constantly exceeding our clients’ expectations of our services and professionalism while helping patients explore all of their treatment options from access to clinical trials through new and innovative therapies, which may have not previously been considered for all cancer patients."